Towards absolute quantification of therapeutic monoclonal antibody in serum by LC− MS/MS using isotope-labeled antibody standard and protein cleavage isotope …
O Heudi, S Barteau, D Zimmer, J Schmidt… - Analytical …, 2008 - ACS Publications
Although LC− MS methods are increasingly used for the absolute quantification of proteins,
the lack of appropriate internal standard (IS) hinders the development of rapid and …
the lack of appropriate internal standard (IS) hinders the development of rapid and …
Comparison of turbulent-flow chromatography with automated solid-phase extraction in 96-well plates and liquid–liquid extraction used as plasma sample preparation …
D Zimmer, V Pickard, W Czembor, C Müller - Journal of Chromatography A, 1999 - Elsevier
Turbulent flow chromatography (TFC) combined with the high selectivity and sensitivity of
tandem mass spectrometry (MS–MS) is a new technique for the fast direct analysis of drugs …
tandem mass spectrometry (MS–MS) is a new technique for the fast direct analysis of drugs …
Matrix effects during analysis of plasma samples by electrospray and atmospheric pressure chemical ionization mass spectrometry: practical approaches to their …
J Schuhmacher, D Zimmer, F Tesche… - … in Mass Spectrometry, 2003 - Wiley Online Library
Some cases of occurrence of matrix effects (mostly ion suppression) in protein‐precipitated
plasma samples, and their influence on the validity of plasma concentrations and …
plasma samples, and their influence on the validity of plasma concentrations and …
New US FDA draft guidance on bioanalytical method validation versus current FDA and EMA guidelines: chromatographic methods and ISR
D Zimmer - Bioanalysis, 2014 - Future Science
Background The wording in this chapter is similar to that in the FDA 2001. It is noted that the
Crystal City III workshop 2006 (CC III)[2] and the AAPS/FDA Workshop on ISR 2008 [3] have …
Crystal City III workshop 2006 (CC III)[2] and the AAPS/FDA Workshop on ISR 2008 [3] have …
Metabolism of the Dual Orexin Receptor Antagonist ACT-541468, Based on Micro-tracer/Accelerator Mass Spectrometry
C Muehlan, H Fischer, D Zimmer… - Current drug …, 2019 - ingentaconnect.com
Background: As part of an integrated and innovative approach to accelerate the clinical
development of the dual receptor antagonist ACT-541468, 6 healthy subjects in one cohort …
development of the dual receptor antagonist ACT-541468, 6 healthy subjects in one cohort …
Detection of photogenotoxicity in skin and eye in rat with the photo comet assay
M Struwe, KO Greulich, U Junker, C Jean… - Photochemical & …, 2008 - Springer
Photosensitizing drugs increase the sensitivity of the skin and the eye toward normally
harmless sunlight conditions and are known to enhance the induction of skin tumors or …
harmless sunlight conditions and are known to enhance the induction of skin tumors or …
Recommendations on the interpretation of the new European Medicines Agency guideline on bioanalytical method validation by Global CRO Council for Bioanalysis …
M Boterman, M Doig, M Breda, S Lowes, J Jersey… - Bioanalysis, 2012 - Future Science
For reprint orders, please contact reprints@ future-science. com principles of Good
Laboratory Practice (GLP) with any aspects of method validation not performed according to …
Laboratory Practice (GLP) with any aspects of method validation not performed according to …
Internal standard application to dried blood spots by spraying: investigation of the internal standard distribution
D Zimmer, S Hassler, B Betschart, S Sack… - Bioanalysis, 2013 - Future Science
Background: The scientifically and logistically best way of application of the internal
standard (IS) in the analysis of dried blood spots (DBS) analysis is still a matter of debate …
standard (IS) in the analysis of dried blood spots (DBS) analysis is still a matter of debate …
Recommendations on bioanalytical method stability implications of co-administered and co-formulated drugs by Global CRO Council for Bioanalysis (GCC)
S Lowes, M Boterman, M Doig, M Breda, J Jersey… - Bioanalysis, 2012 - Future Science
An open letter written by the Global CRO Council for Bioanalysis (GCC) describing the GCC
survey results on stability data from co-administered and co-formulated drugs was sent to …
survey results on stability data from co-administered and co-formulated drugs was sent to …
Recommendations on ISR in multi analyte assays, QA/bioanalytical consultants and GCP by Global CRO Council for Bioanalysis (GCC)
T Sangster, J Maltas, P Struwe, J Hillier, M Boterman… - Bioanalysis, 2012 - Future Science
The Global CRO Council for Bioanalysis (GCC) was formed in an effort to bring together
many senior-level representatives of CROs to openly discuss bioanalysis and the regulatory …
many senior-level representatives of CROs to openly discuss bioanalysis and the regulatory …